Practical Implications of IEC
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1 ggf. externes Logo Practical Implications of IEC The legal perspective. Jens Heuer-James, Attorney at Law Kopenhagen, October 4, 2016 Rechts- und Steuerberatung
2 Yes Yes No No No Yes Yes Yes No No Yes No 2
3 How do we identify the practical aspects? Step 1: General aspects of the practical implication. We know technical standards in an extreme board variety. Consequently it seems to be likely that these standards have a different practical implication in particular with regards to the legal perspective. The task is to clarify the concrete situation with regards to IEC Step 2: Practical impact for your business. IEC is a framework for drafting the user information. The requirements stipulated therein have to be applied to the individual products. For the individual products individual legal rules do apply. Consequently the general aspects of the practical implication have to be individualized to create a benefit for your business. 3
4 Step 1: General aspects of practical implication.
5 Legal requirements an overview Supplier I Contract Manufacturer Supplier II Contract Contract Contract Supplier Z Dealer Product Safety Law Contract Market Surveillance Authority Product Safety Law Customer User Product Liability
6 Requirements stipulated by the contract Legal requirements Contracts Requirements stipulated by the contract Explicit Specification (Contract and published product descriptions) Usual Specification Specification needed to fufill expectations Requirements stipulated by the contract Requirements stipulated by the contract
7 Legal requirements Contracts What do we want with regards to a contract? A contract shall reflect the understanding of both parties ultimately clear and precise to provide them with clear instructions for performing the rights and obligations stipulated within the contract to create the maximum of a risk management in the understanding of avoiding any liability based on infringement of contract obligations The consequence is clear: The specifications written in or referred to by the contract shall be completely and leave no space for the applications of the rules stipulated in the contract law dealing with usual specifications and expectations. 7
8 Legal requirements - contracts IEC offers Content Safety Informaton Comprehensibility Annexes Transport Safety Notes Structure Evaluation Installation Warnings Language Conformity Operation Risk classes Communication Effectiveness Maintenance Risk Assessment Media Preparation 8
9 Legal requirements Contracts Question: Is it appropriate to refer with the sentence IEC shall govern all requirements with regards to the user information to IEC to draft a clear and precise specification? Answer: No, it is not appropriate. IEC consists of different content describing general principles as well as internal, organizational aspects and does not focus on the user information as such. Solution: A general reference is not appropriate. A concrete reference shall be used instead. 9
10 Legal requirements Contracts Exampel A for a specification by reference to IEC : 10
11 Legal requirements Contracts Exampel B for a specification by reference to IEC : 11
12 Legal requirements Contracts Exampel C for a specification by reference to IEC
13 Legal requirements Contracts Exampel D for a specification by reference to IEC
14 Legal requirements - Contracts IEC can be used for specification Content Safety Informaton Comprehensibility Annexes Transport Safety Notes Structure Evaluation Installation Warnings Language Conformity Operation Risk classes Communication Effectiveness Maintenance Risk Assessment Media Preparation 14
15 Legal requirements Product Liability 15
16 Legal requirements Product Liability You can t idiot-proof the product and the good news is, that you don t have to. (zit. Nach Robinson / Etter, 2000) 16
17 Legal requirements Product Liability The product has to be accompanied by an adequate user information which allows the use to execute a proper risk-benefit-analysis for the product and to avoid any risk by using the product within the range being foreseeable for the manufacturer. Potential risk have to be highlighted be proper warnings: 17
18 Legal requirements Product Liability Complexity of the product Adequate = adequate reflection of Expectations of the user User skills and experiences Product risk assessment Local requirements by culture/law 18
19 Legal requirements Product Liability Complexity of the product: 5 Adequate = adequate reflection of Expectations of the user: 6 User skills and experiences: 4.4 Product risk assessment: 4.3 Local requirements by culture/law 19
20 Legal requirements Product Safety Law Legal Framework CE marking (NLF) Product Safety Local Law (e.g. ProdSG) Art. R 2 subpara 7 Art. 6 subpara 1c) unsafe products Art. R 4 subpara 4 Art. 6 subpara 1e) information as indicator Art. R 5 subpara 2 Art. 8 subpara 8 general requirements Annexes (if any) Art. 10 subpara 4 language requirements 20
21 Legal requirements Product Safety Law A product will be deemed to be safe Requirements of the CE- Directives Products are deemed to be safe if compliant with Standards General Requirements dealing with the Safety of Products
22 Legal requirements Product Safety Law According to Danish Product Safety Act a product will be deemed as safe, if
23 Legal requirements Product Safety Law 23
24 Legal requirements Product Safety Law IEC is not a harmonised standard with presumption of conformity! Consequence: IEC is irrelevant for market surveillance? No. IEC is not irrelevant because. Market Surveillance Authorities need to analyse the safety of products based on technical standard, because the analyse has to be executed as soon as possible which does exclude excessive detailed analysing. In practise the Market Surveillance Authorities do refer to any available technical standard which seems to be useful for a risk assessment. German Market Surveillance Authorities do refer to IEC (as EN ) and do very often ask for the fulfilment of the standard as a basis for drafting the user information. 24
25 Legal requirements Product Safety Law IEC shall referred to in minimum within the technical file: 25
26 Step 2: Practical impact for your business.
27 Practical implications for your business This section has been intentionally left blank. 27
28 Thank you!
29 Your contact: Jens-Uwe Heuer-James Attorney at Law (Rechtsanwalt) Luther Rechtsanwaltsgesellschaft mbh Partner Berliner Allee Hannover Telefon
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